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A Prospective, Multicentre, Controlled, Observational Study to Evaluate the Performance of Patient Support Programme (PSP) in Improving Patient Adherence With Adjuvant Aromatase Inhibitors (AI) Medication for Postmenopausal, Early Stage Breast Cancer


N/A
N/A
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Prospective, Multicentre, Controlled, Observational Study to Evaluate the Performance of Patient Support Programme (PSP) in Improving Patient Adherence With Adjuvant Aromatase Inhibitors (AI) Medication for Postmenopausal, Early Stage Breast Cancer


Inclusion Criteria:



- Provide signed and dated written Informed Consent

- Have been taking upfront AI adjuvant therapy in line with current SmPC

- Be capable of completing drug intake by herself

- Be capable of understanding Chinese

Exclusion Criteria:

- Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has
not been granted by SFDA

- Upfront adjuvant AI medication which has exceeded over eight weeks

- Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than
AI

- Involvement in the planning and conduct of the study (applies to both AstraZeneca
staff or staff at the study site)

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

compare the 1-year adherence

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Karen Atkin

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

China: Ethics Committee

Study ID:

NIS-OCN-ARI-2008/1

NCT ID:

NCT00769080

Start Date:

September 2008

Completion Date:

October 2010

Related Keywords:

  • Breast Cancer
  • PSP
  • Standard Treatment
  • Standard Treatment plus PSP
  • Breast Neoplasms

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